The Basics

What is Ipilimumab?

Approved to treat patients who have advanced stages of melanoma.

Brand names for Ipilimumab

Yervoy

How Ipilimumab is classified

Antibodies – Monoclonal, Antineoplastic Agents, Biological Response Modifiers, Immunologic Adjuvants, Immune Checkpoint Inhibitors

Ipilimumab During Pregnancy

Ipilimumab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ipilimumab while pregnant

N/A

Taking Ipilimumab While Breastfeeding

What are recommendations for lactation if you're taking Ipilimumab?

The amount of ipilimumab in breastmilk appears to be very low, but it may increase with subsequent doses during a treatment cycle. Absorption from the infant’s gastrointestinal tract is unknown. Because ipilimumab is a large protein molecule with a molecular weight of 148,000, absorption is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant’s gastrointestinal tract. Until more data become available, ipilimumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during ipilimumab therapy and for 3 months after the last dose. Ipilimumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

The amount of ipilimumab in breastmilk appears to be very low, but it may increase with subsequent doses during a treatment cycle. Absorption from the infant’s gastrointestinal tract is unknown. Because ipilimumab is a large protein molecule with a molecular weight of 148,000, absorption is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant’s gastrointestinal tract. Until more data become available, ipilimumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during ipilimumab therapy and for 3 months after the last dose. Ipilimumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Possible effects of Ipilimumab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ipilimumab

None listed

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Koenig A, de Albuquerque Diniz EM, Barbosa SF et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439-43. PMID: 16280560
2. Adhisivam B, Vishnu Bhat B, Rao K et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2018;1-4. PMID: 29587541
3. Rodriguez-Camejo C, Puyol A, Fazio L et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137-47. PMID: 28586632
4. Ross E, Robinson SE, Amato C et al. Therapeutic monoclonal antibodies in human breast milk: A case study. Melanoma Res. 2014;24:177-80. PMID: 24476799

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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